A Phase II Trial of Rivoceranib, an Oral Vascular Endothelial Growth Factor Receptor 2 Inhibitor, for Recurrent or Metastatic Adenoid Cystic Carcinoma

被引:13
|
作者
Hanna, Glenn J. [1 ]
Ahn, Myung-Ju [2 ]
Muzaffar, Jameel [3 ]
Keam, Bhumsuk [4 ]
Bowles, Daniel W. [5 ]
Wong, Deborah J. [6 ]
Ho, Alan L. [7 ]
Kim, Sung-Bae [8 ]
Worden, Francis [9 ]
Yun, Tak [10 ]
Meng, Xianzhang [11 ]
Van Tornout, Jan M. [11 ,13 ]
Conlan, Maureen G. [11 ]
Kang, Hyunseok [12 ,14 ]
机构
[1] Dana Farber Canc Inst, Ctr Salivary & Rare Head & Neck Canc, Boston, MA USA
[2] Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Dept Hematol & Oncol, Seoul, South Korea
[3] H Lee Moffitt Canc Ctr & Res Inst, Dept Head & Neck Endocrine Oncol, Tampa, FL USA
[4] Seoul Natl Univ Hosp, Coll Med, Seoul, South Korea
[5] Univ Colorado, Dept Med Med Oncol, Anschutz Med Campus, Aurora, CO USA
[6] Univ Calif Los Angeles, Dept Head & Neck Med Oncol, Los Angeles, CA USA
[7] Weill Cornell Med Coll, Mem Sloan Kettering Canc Ctr, Dept Head & Neck Med Oncol, New York, NY USA
[8] Univ Ulsan, Coll Med, Asan Med Ctr, Seoul, South Korea
[9] Univ Michigan, Michigan Med, Rogel Canc Ctr, Ann Arbor, MI USA
[10] Natl Canc Ctr, Goyang, South Korea
[11] Elevar Therapeut, Ft Lee, NJ USA
[12] Univ Calif San Francisco, Dept Radiat Oncol, San Francisco, CA 94158 USA
[13] BIO PHARMA eCONSULTING, Los Angeles, CA USA
[14] Univ Calif San Francisco, 1825 4th St, San Francisco, CA 94158 USA
关键词
SALIVARY-GLANDS; SURVIVAL; CRITERIA; AXITINIB; TUMORS;
D O I
10.1158/1078-0432.CCR-23-1030
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: This open-label, single-arm, phase II study evaluated the vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) rivoceranib in patients with recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC).Patients and Methods: Eligible patients had confirmed disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) with >= 20% increase in radiologically or clinically measurable lesions or appearance of new lesions within the preceding 6 months. Patients received oral rivoceranib 700 mg once daily. Primary outcomes were objective response rate (ORR) by investigator review and by blinded independent review committee (BIRC).Results: Eighty patients were enrolled and 72 were efficacy evaluable. Seventy-four patients had distant metastases and 49 received prior systemic treatment (14 received VEGFR TKIs). Per investigator and BIRC, respectively, ORR was 15.3% [95% confidence interval (95% CI), 7.9-25.7] and 9.7% (95% CI, 4.0-19.0); median duration of response was 14.9 months (95% CI, 4.9-17.3) and 7.2 months (95% CI, 3.5-8.4); and median progression-free survival was 9.0 months (95% CI, 7.3-11.5) and 9.0 months (95% CI, 7.7-11.5). Grade >= 3 treatment-related adverse events occurred in 56 patients (70.0%); the most common were hypertension (34, 42.5%) and stomatitis (6, 7.5%). Four grade 5 events occurred with one attributed to rivoceranib (epistaxis). Sixty-eight patients (85.0%) had >= 1 dose modifications and 16 patients (20.0%) discontinued rivoceranib for toxicity.Conclusions: In patients with progressing R/M ACC, rivoceranib demonstrated antitumor activity and a manageable safety profile consistent with other VEGFR TKIs.
引用
收藏
页码:4555 / 4563
页数:9
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